Drug · FAERS side-effect profile with label screen
Zinc side effects: what 24,498 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Zincum Metallicum
openFDA label
Who reports
24,498 reports · 56% serious · 1,499 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Leg Cramps
FDA label, Indications and Usage
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 4Lab value / disease marker 4No label text to screen 32
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,160 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Amyloid arthropathy | 52 | 3,652.6 1,950.1–6,841.6ROR 3,660.4 · calibrated p 6e-21 ✓ | 546.9 EB05 433.1 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=52 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Radiation inflammation | 28 | 453.9 286.7–718.4ROR 454.4 · calibrated p 2e-12 ✓ | 245.9 EB05 178.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=28 · ♀ 0% (drug 66%) | not reported in cached trials |
| Copper deficiency | 21 | 190.3 118.6–305.6ROR 190.5 · calibrated p 4e-9 ✓ | 136.4 EB05 94.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 100% clinician | not reported in cached trials |
| Sedation complication | 314 | 122.9 109.2–138.2ROR 124.5 · calibrated p 2e-8 ✓ | 106.7 EB05 97.1 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=314 · ♀ 100% (drug 66%) | not reported in cached trials |
| Rhinocerebral mucormycosis | 30 | 82.1 56.4–119.4ROR 82.2 · calibrated p 1e-6 ✓ | 71.6 EB05 52.6 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 · 100% clinician | not reported in cached trials |
| Multiple drug therapy | 61 | 81.9 63.0–106.5ROR 82.1 · calibrated p 7e-7 ✓ | 73.1 EB05 58.9 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious n=61 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Creatinine renal clearance decreased | 322 | 74.3 66.3–83.2ROR 75.2 · calibrated p 1e-6 ✓ | 68.1 EB05 62.0 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=322 · ♀ 100% (drug 66%) | not reported in cached trials |
| Carbuncle | 21 | 68.6 44.0–107.0ROR 68.7 · calibrated p 5e-6 ✓ | 60.2 EB05 41.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · ♀ 100% (drug 66%) | not reported in cached trials |
| Creatinine renal clearance increased | 50 | 60.9 45.7–81.1ROR 61.0 · calibrated p 6e-6 ✓ | 55.7 EB05 43.9 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=50 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Appendicolith | 24 | 57.6 38.1–87.1ROR 57.7 · calibrated p 1e-5 ✓ | 51.9 EB05 36.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 0% (drug 66%) · 100% clinician | not reported in cached trials |
| Necrosis ischaemic | 21 | 40.6 26.2–62.9ROR 40.6 · calibrated p 1e-4 ✓ | 37.6 EB05 25.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Pulmonary pain | 104 | 32.1 26.4–39.0ROR 32.2 · calibrated p 2e-4 ✓ | 30.8 EB05 26.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=99 | not reported in cached trials |
| Blood calcium decreased | 358 | 28.0 25.2–31.1ROR 28.4 · calibrated p 4e-4 ✓ | 27.1 EB05 24.8 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 33.6 · ♀ 97% (drug 66%) | not reported in cached trials |
| Sinusitis fungal | 25 | 28.0 18.8–41.7ROR 28.0 · calibrated p 6e-4 ✓ | 26.6 EB05 19.0 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=25 · 100% clinician | not reported in cached trials |
| Genital ulceration | 22 | 25.6 16.7–39.1ROR 25.6 · calibrated p 1e-3 ✓ | 24.4 EB05 16.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | not reported in cached trials |
| Facet joint syndrome | 88 | 24.5 19.9–30.3ROR 24.6 · calibrated p 8e-4 ✓ | 23.8 EB05 19.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=88 · ♀ 100% (drug 66%) | not reported in cached trials |
| Peripheral venous disease | 110 | 24.2 20.0–29.2ROR 24.3 · calibrated p 9e-4 ✓ | 23.5 EB05 20.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=107 · ♀ 100% (drug 66%) | not reported in cached trials |
| Monoclonal immunoglobulin present | 21 | 24.1 15.6–37.2ROR 24.1 · calibrated p 0.001 ✓ | 23.0 EB05 15.8 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=21 · ♀ 100% (drug 66%) | not reported in cached trials |
| Onychomycosis | 115 | 23.0 19.1–27.7ROR 23.1 · calibrated p 0.001 ✓ | 22.4 EB05 19.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=108 · ♀ 100% (drug 66%) | not reported in cached trials |
| Bronchopulmonary aspergillosis allergic | 21 | 20.0 13.0–30.9ROR 20.0 · calibrated p 0.003 ✓ | 19.2 EB05 13.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 | not reported in cached trials |
| Rheumatic fever | 100 | 20.0 16.4–24.4ROR 20.1 · calibrated p 0.002 ✓ | 19.5 EB05 16.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=100 · ♀ 100% (drug 66%) · 90% clinician | not reported in cached trials |
| Onychomadesis | 95 | 20.0 16.3–24.5ROR 20.1 · calibrated p 0.002 ✓ | 19.5 EB05 16.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=94 · ♀ 100% (drug 66%) | not reported in cached trials |
| Infusion site discharge | 39 | 19.9 14.5–27.4ROR 20.0 · calibrated p 0.003 ✓ | 19.3 EB05 14.7 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · 100% consumer | not reported in cached trials |
| Finger deformity | 107 | 19.3 15.9–23.3ROR 19.4 · calibrated p 0.003 ✓ | 18.8 EB05 16.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=105 · ♀ 100% (drug 66%) | not reported in cached trials |
| Orthostatic hypotension (dizziness on standing) | 354 | 17.7 15.9–19.6ROR 17.9 · calibrated p 0.003 ✓ | 17.3 EB05 15.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.9 · ♀ 96% (drug 66%) | not reported in cached trials |
| Pneumonia streptococcal | 22 | 17.5 11.5–26.6ROR 17.5 · calibrated p 0.005 ✓ | 16.7 EB05 11.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=22 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Female genital tract fistula | 32 | 16.2 11.4–23.0ROR 16.2 · calibrated p 0.006 ✓ | 15.6 EB05 11.5 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Beta haemolytic streptococcal infection | 23 | 15.9 10.6–24.1ROR 16.0 · calibrated p 0.007 ✓ | 15.3 EB05 10.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Renal function test abnormal | 82 | 15.5 12.5–19.3ROR 15.6 · calibrated p 0.007 ✓ | 15.2 EB05 12.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=78 · ♀ 100% (drug 66%) | not reported in cached trials |
| Sinus pain | 41 | 15.5 11.4–21.0ROR 15.5 · calibrated p 0.007 ✓ | 15.0 EB05 11.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=35 · ♀ 100% (drug 66%) | not reported in cached trials |
| Hypothalamo-pituitary disorder | 25 | 15.1 10.1–22.3ROR 15.1 · calibrated p 0.009 ✓ | 14.4 EB05 10.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 · ♀ 100% (drug 66%) | not reported in cached trials |
| Macrocytosis | 20 | 14.9 9.6–23.2ROR 14.9 · calibrated p 0.010 ✓ | 14.1 EB05 9.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | not reported in cached trials |
| Product label confusion | 97 | 14.5 11.9–17.7ROR 14.5 · calibrated p 0.009 ✓ | 14.2 EB05 11.9 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=97 · ♀ 100% (drug 66%) | not reported in cached trials |
| Genital pain | 24 | 14.1 9.4–21.1ROR 14.1 · calibrated p 0.012 ✓ | 13.4 EB05 9.1 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · ♀ 0% (drug 66%) | not reported in cached trials |
| Congenital anomaly | 122 | 13.6 11.4–16.2ROR 13.6 · calibrated p 0.011 ✓ | 13.3 EB05 11.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.7 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Blepharospasm | 94 | 13.1 10.7–16.1ROR 13.2 · calibrated p 0.013 ✓ | 12.8 EB05 10.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=93 · ♀ 100% (drug 66%) | not reported in cached trials |
| Infusion site bruising | 32 | 13.0 9.2–18.5ROR 13.1 · calibrated p 0.015 ✓ | 12.5 EB05 9.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · 100% consumer | not reported in cached trials |
| Fistula discharge | 19 | 13.0 8.3–20.4ROR 13.0 · calibrated p 0.017 ✓ | 12.0 EB05 7.6 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=19 | not reported in cached trials |
| Nail disorder | 120 | 12.0 10.0–14.3ROR 12.0 · calibrated p 0.018 ✓ | 11.7 EB05 10.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=114 · ♀ 91% (drug 66%) | not reported in cached trials |
| Breast cancer stage iii | 88 | 11.8 9.6–14.6ROR 11.9 · calibrated p 0.019 ✓ | 11.5 EB05 9.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=88 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Zinc as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00148733 — CHIZAP: Community- and Health Facility-Based Intervention With Zinc as Adjuvant Therapy for Childhood Pneumoni (N=2628, PHASE2, PHASE3; 1 AE terms posted; arms: Zinc; Placebo)
- NCT01857310 — Folic Acid and Zinc Supplementation Trial (FAZST) (N=2370, NA; 15 AE terms posted; arms: Folic Acid and Zinc Supplementation; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 2,610 | 2.9 2.8–3.0ROR 3.1 · calibrated p 0.594 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.3 | not reported in cached trials |
| Pain | 1,926 | 2.7 2.6–2.8ROR 2.8 · calibrated p 0.686 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | NCT01857310: 1/1,185 (0.1%) on Zinc (serious AE) |
| Nausea | 1,897 | 2.1 2.0–2.1ROR 2.1 · calibrated p 0.978 | 2.1 EB05 2.0 · IC025 +1.0 | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,879 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.761 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | not reported in cached trials |
| Headache | 1,823 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.766 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | not reported in cached trials |
| Off label use (used outside approved label) | 1,795 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.848 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.2 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,505 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.291 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,469 | 2.2 2.1–2.3ROR 2.3 · calibrated p 0.902 | 2.2 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | not reported in cached trials |
| Dizziness | 1,326 | 2.3 2.2–2.4ROR 2.4 · calibrated p 0.878 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.6 | not reported in cached trials |
| Arthralgia (joint pain) | 1,324 | 2.7 2.6–2.9ROR 2.8 · calibrated p 0.682 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 | not reported in cached trials |
| Fall | 1,257 | 3.2 3.1–3.4ROR 3.4 · calibrated p 0.520 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | not reported in cached trials |
| Asthenia (weakness) | 1,239 | 2.8 2.7–3.0ROR 2.9 · calibrated p 0.653 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | not reported in cached trials |
| Constipation | 1,104 | 4.4 4.1–4.6ROR 4.5 · calibrated p 0.291 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | not reported in cached trials |
| Rash | 1,091 | 2.2 2.0–2.3ROR 2.2 · calibrated p 0.947 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | not reported in cached trials |
| Cough | 979 | 3.0 2.8–3.2ROR 3.1 · calibrated p 0.600 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | not reported in cached trials |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Zinc?
In FDA FAERS, the most frequently co-reported reaction terms for Zinc are fatigue, pain, nausea, diarrhoea, headache, dyspnoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Zinc have an FDA boxed warning?
No. The FDA label retrieved for Zinc has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Zinc causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0eba1030-7c33-11e6-8959-424c58303031, effective 20230720; matched on
openfda.generic_name.exact:"ZINC") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,200 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
ZINC, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.